RadProtect for Radiation Protection

Overseen By San Tseng

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Original BioMedicals Co. Ltd.

Must not be taking: Hormone replacement therapy

Disqualifiers: Diabetes, Hypertension, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of RadProtect®, a new treatment designed to protect against radiation exposure. RadProtect® releases a protective agent called amifostine into the bloodstream. The trial seeks healthy volunteers with normal blood pressure, within a specific weight range, and without serious medical conditions. Participants should not be taking hormone replacement therapy or have a history of diabetes or heart issues. As a Phase 1 trial, this research focuses on understanding how RadProtect® works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the RadProtect trial?

The trial protocol does not specify if you must stop taking your current medications, but you must agree to abstain from taking unauthorized medications or supplements during the trial.

Is there any evidence suggesting that RadProtect® is likely to be safe for humans?

RadProtect® is a new treatment under testing to protect against radiation. Currently, limited information exists about its safety in humans, as it remains in the early testing stages. Researchers are primarily assessing how well people tolerate the treatment and identifying any side effects. As a Phase 1 trial, this marks the initial step in determining the treatment's safety. Typically, Phase 1 trials focus on safety and understanding the body's reactions. Specific safety data for RadProtect® is not yet available, but the trial aims to ensure it is well-tolerated by healthy volunteers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about RadProtect® because it offers a novel approach to radiation protection. Unlike traditional treatments, which often rely on antioxidants or other chemical agents, RadProtect® uses a unique micelle structure involving ferrous iron to release the active ingredient, amifostine, into the bloodstream. This innovative delivery method could potentially enhance the effectiveness and safety of radiation protection by targeting transferrin and related proteins, making it a promising alternative to current options.

What evidence suggests that RadProtect® might be an effective treatment for radiation protection?

Research shows that RadProtect®, the investigational treatment in this trial, aims to protect the body from radiation damage. It uses tiny particles called micelles to release a drug named amifostine into the bloodstream. Amifostine is known to protect cells from harm. Previous studies have shown that amifostine can help reduce side effects caused by radiation. Although limited data exists on RadProtect® in humans, its mechanism suggests it could offer significant protection against radiation. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Healthy adults aged 18-64 with normal blood pressure and BMI of 18-30 kg/m^2 can join. They must not have diabetes, heart, liver, or kidney diseases, active cancer, or certain other conditions. Participants need to use reliable contraception and avoid other trials or experimental treatments.

Inclusion Criteria

I am using effective birth control and will continue for 60 days after the trial.

Subjects who agree to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial.

My BMI is between 18 and 30.

Exclusion Criteria

You drink more than five alcoholic beverages every week.

Subjects who are pregnant or lactating

I am allergic to glutamate acid, polyethylene glycol, or ingredients in the test medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RadProtect® intravenous injection and are monitored for safety and pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including dose limiting toxicity and pharmacokinetic analysis

28 days

3 telephone visits on Day 3, Day 14+2, and Day 28+2

What Are the Treatments Tested in This Trial?

Interventions

• RadProtect®

Trial Overview The trial is testing RadProtect®, a new drug for preventing radiation injury. It's an early-stage study where volunteers receive increasing doses to check the drug's safety and how it moves through the body over time.

How Is the Trial Designed?

Group I: RadProtect® Experimental Treatment 1 Intervention

RadProtect® is not a full-closed micelle, and uses ferrous iron to provide linkage between PEG-b-PGA and amifostine. Transferrin and other related proteins can chelate with ferrous iron and break the micelle releasing amifostine into the blood stream.

Who Is Running the Clinical Trial?

Original BioMedicals Co. Ltd.

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

The RADPAD surgical drape significantly reduces radiation exposure to primary operators during routine diagnostic coronary angiography, with a 59% reduction in total radiation exposure and a 47% reduction in the radiation exposure rate.

In a study involving 60 patients, the primary operator's radiation dose was significantly lower when using the RADPAD (8.0 µSv) compared to the control group (19.6 µSv), indicating its efficacy in protecting healthcare staff from ionizing radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protective drape during coronary angiography. Kherad, B., Jerichow, T., Blaschke, F., et al.[2019]

In a study involving 137 patients undergoing coronary angiography and percutaneous coronary intervention, the use of RADPAD significantly reduced radiation exposure for the primary operator (PO) compared to procedures without it, with reductions in dose relative to various measures (CAST, DAP, and AK).

The findings also indicated that secondary operators (SO) experienced similar reductions in radiation exposure when RADPAD was used, highlighting its effectiveness in enhancing safety during fluoroscopic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimizing scattered radiation dose in cardiac catheterization laboratory during interventional procedures using lead free drape - MILD study. Bhat, KG., Guleria, VS., Singla, M., et al.[2022]

In a randomized study of 60 patients undergoing coronary angiography, the use of the Radpad radiation shield significantly reduced the operator's radiation exposure by 23%, despite similar procedure times and total examination doses.

The Radpad shield provided consistent reductions in radiation exposure across various body locations, ranging from 13% to 34%, highlighting its effectiveness in protecting healthcare workers during interventional procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield. Politi, L., Biondi-Zoccai, G., Nocetti, L., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-radiation-injuries-9-2015-31828

RadProtect for Radiation Protection · Info for Participants The Radpad shield provided consistent reductions in radiation exposure across various body locations, ranging from 13% to 34%, highlighting its effectiveness ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/results/NCT02587442

A Study to Evaluate the Safety and Pharmacokinetics ... A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers. ClinicalTrials.gov ID NCT02587442. Sponsor Original ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7467366/

Radioprotectors.org: an open database of known and ... We have created an open database, Radioprotectors.org, containing an up-to-date list of substances with proven radioprotective properties.

4. researchgate.net researchgate.net/publication/280586689_CCM-AMI_a_Polyethylene_Glycol_Micelle_with_Amifostine_as_an_Acute_Radiation_Syndrome_Protectant_in_C57BL6_Mice

CCM-AMI, a Polyethylene Glycol Micelle with Amifostine ... RadProtect utilizes micelle nanoparticles to confer radiation protection via release of the cytoprotective drug amifostine, and is being ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0753332218337922

Appraisal of mechanisms of radioprotection and ... These agents have a very important role in enhancing the quality of life of cancer survivors after radiotherapy by alleviating radiation induced side effects [5 ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557499/

Radiation Safety and Protection - StatPearls - NCBI Bookshelf Radiation protection aims to reduce unnecessary radiation exposure with a goal to minimize the harmful effects of ionizing radiation.

7. www-pub.iaea.org www-pub.iaea.org/MTCD/Publications/PDF/Pub1578_web-57265295.pdf

Radiation Protection and Safety of Radiation Sources Radiation protection and safety of radiation sources : international basic safety standards. — Vienna : International Atomic Energy Agency, 2014. p. ; 24 cm. — ...

8. youtube.com youtube.com/watch?v=8dH1QVwIsN0

Radiation Protection in Radiology | Introduction In this chapter we will discuss how ionizing radiation is emitted and we will explain the fundamental principles of radiation protection.

9. epa.gov epa.gov/radiation

Radiation Protection | US EPA EPA sets environmental standards and provides technical expertise to protect human health and the environment from the use of radioactive materials.